This invention relates generally to intraocular lenses and injectors and, more particularly, to apparatus for holding intraocular lenses, apparatus for holding intraocular lens injectors, combinations including such apparatus and methods for loading intraocular lens into injectors using such apparatus and combinations.
As is well known, intraocular lenses or IOLs are used in the eye, for example, as an adjunct to the natural lens of the eye or to replace the natural lens of the eye when the natural lens becomes damaged or otherwise incapable of functioning. For example, the natural lens may be removed and an IOL is inserted into the eye as a direct replacement. A typical IOL includes an optic or lens body for focusing light toward the retina of the eye, and one or more fixation members or haptics for fixing the IOL in the desired position within the eye.
The IOL preferably is implanted directly into the eye through a small incision formed in the ocular tissue of the eye. To fit through this small incision, optics of modern IOLs are designed to be deformed, e.g., folded, rolled or the like, to a relatively small profile and then allowed to substantially return to their original shape within the eye.
The IOL is typically provided to the surgeon or other medical personnel in a packaging system which contains the IOL. These packaging devices protect the IOL during handling and transportation to the surgical site and may even allow for accurately folding the IOL along the optic diameter in order to reduce its size. Some of these systems specifically fold the IOL in preparation for grasping by the forceps or other surgical instrument. One form of such a holding and folding device or system is described in Buboltz et al U.S. Pat. No. 5,171,241.
A very useful technique for inserting an IOL into the eye includes the use of an IOL injector or cartridge, such as the IOL injector described in Bartell, U.S. Pat. No. 4,681,102. These IOL injectors include a load chamber which is connected to an injection tube. The load chamber includes an openable first lumen for receiving the IOL. Closure of this first lumen folds the IOL and maintains the IOL in a folded state. The injection tube includes a small diameter distal tip which is insertable into the incision within the eye. The IOL is transferable from the load chamber through the injection tube and into the eye. These IOL injectors simplify the placement of the IOL within the eye and reduce chances of surgeon error.
A very useful IOL packaging system is disclosed in commonly assigned U.S. patent application Ser. No. 08/987,864, filed on Dec. 9, 1997, the disclosure of which is hereby incorporated in its entirety herein by reference. The IOL is placed on the load chamber so that the IOL will be folded when the load chamber is closed.
The technique of transferring the IOL to the load chamber of the injector normally is accomplished by manually manipulating the IOL and/or injector. Such manual manipulation requires a relatively high degree of dexterity and can result in the IOL being incorrectly loaded in the injector. Also, increased handling increases the risk of damaging and/or contaminating the IOL and/or injector.
It would be advantageous to provide an IOL injector holding system so that the IOL could be placed in the injector with reduced, or even substantially no, manual manipulation.
Apparatus for holding intraocular lens injectors, combinations of intraocular lens injector holding assemblies and intraocular lens holding assemblies, intraocular lens packaging systems and methods for using intraocular lens injector holding apparatus and assemblies have been discovered. The present intraocular lens injector holding apparatus and assemblies provide enhanced ease of use, for example, by requiring reduced dexterity to load an IOL into an injector and/or by simplifying or eliminating individual steps previously required to load the IOL. For example, the IOL injector preferably does not have to be manually handled except to place the injector into an injector system hand piece for insertion of the IOL into the eye. The present invention reduces the risk of dust or other contamination on the IOL, as well as reducing the risk of damaging the IOL injector. Additional benefits include the provision for holding a soft tip for use on a push rod of the IOL injection system. Also, additional lubricants, such as aqueous balanced salt solution (BSS) and/or visco elastic materials, can be added in the injector while it is still being held by the holding apparatus or assembly. The present apparatus, combinations, systems and methods are straightforward in construction and are relatively easy and convenient to manufacture, use and practice.
In one broad aspect of the present invention, apparatus for holding an intraocular lens injector or cartridge having a load or loading chamber, and preferably a pair of generally opposing wings, so that the loading chamber is maintained in an open position are provided. The apparatus comprises a housing and at least one element, preferably a plurality of such elements. The housing is sized and adapted to receive the intraocular lens injector. The element or elements are secured to the housing and are adapted and positioned to stabilize the position of the intraocular lens injector relative to the housing, for example, to hold the intraocular lens injector in or to the housing, with the loading chamber in the open position.
The present apparatus for holding an intraocular lens injector may be considered a package system for such intraocular lens injectors. Thus, the intraocular lens injector may be included with the apparatus at the point of manufacture or assembly of the intraocular lens injector. In this fashion, the surgeon or technician at the surgical site does not need to handle the intraocular lens injector prior to placing the intraocular lens into the injector.
Preferably, the intraocular lens injector has a proximal end, and one of the elements of the present apparatus is positioned to be in proximity, or even substantially abutting relation, to this proximal end. The intraocular lens injector includes an injection tube located distally of the loading chamber. One or more of the elements of the present apparatus preferably are positioned to contact the injection tube, for example, to stabilize the position of the injection tube, and more preferably to hold the injector to the housing. In a useful embodiment, one or more elements are positioned to be in proximity to the proximal end of the injector and one or more elements are positioned to contact the injection tube. Other configurations of these elements may be employed and are included within the scope of the present invention. These elements preferably are positioned so as to facilitate maintaining the injector in a substantially fixed position so that the intraocular lens can be placed in the loading chamber in the proper orientation for insertion into the eye.
The present intraocular lens injector holding apparatus preferably further include support members secured to the housing and adapted and positioned so that at least one of the support members is in close proximity to each of the wings of the received intraocular lens injector. Thus, both wings are provided with such support member or members located in close proximity thereto, for example, so that the wings are effectively positioned to facilitate the use of the injector holding apparatus with the intraocular lens holding assembly, as is discussed elsewhere herein.
The housing may include a base, with the element or elements secured to the base and extending therefrom.
In one embodiment, the housing includes a sidewall extending from, preferably extending generally upwardly from, the base. More preferably, the housing includes a peripheral sidewall which substantially fully or completely circumscribes the base. Such sidewall is effective, for example, to protect the intraocular lens injector during shipment, storage and handling.
In a very useful embodiment, the sidewall includes at least one projection extending inwardly. The injector holding apparatus further comprises at least one mounting member secured to the housing and spaced apart from the at least one projection. Preferably, the apparatus includes two of these projections and two of the mounting members positioned so that each projection is aligned with and spaced apart from a different mounting member. The projection or projections and mounting member or members combinations are very effective in facilitating the placement of the intraocular lens into the intraocular lens injectors, as is described elsewhere herein.
The present intraocular lens injector holding apparatus advantageously further comprises a tip holder secured to the housing, preferably to the base of the housing. This tip holder is sized and adapted to hold a tip, for example, a soft tip made of polymeric material, such as silicone polymeric material, to be placed on the distal end of a push rod used in inserting an intraocular lens into the eye. Thus, the present intraocular lens injector holding apparatus not only provides for an easy and convenient way to provide the IOL in the injector, but also preferably allows the surgeon to very conveniently place the tip on the push rod prior to inserting the IOL into the eye.
The present intraocular lens injector holding apparatus preferably are made of polymeric materials, although other materials of construction may be employed. In one very useful embodiment, the present apparatus are unitary in construction, that is have a single piece construction.
In another broad aspect of the present invention, useful combinations are provided which comprise an intraocular lens injector holding assembly and an intraocular lens holding assembly. An intraocular lens injector or cartridge may be removably held to the injector holding assembly. An IOL, including a deformable optic, may be removably retained by the intraocular lens holding assembly. The injector holding assembly and the intraocular lens holding assembly are adapted to cooperate in transferring the intraocular lens to the injector. The intraocular lens holding assembly preferably is further adapted to receive and hold the intraocular lens injector. The injector holding assembly and lens holding assembly advantageously are further adapted to cooperate to directly transfer the injector from the injector holding assembly to the lens holding assembly. In one embodiment, the lens holding assembly is still further adapted so that the transferred injector is manually removable from the lens holding assembly together with the IOL. The injector, with the IOL positioned therein, can then be used in inserting the IOL into an eye.
The intraocular lens injector holding assemblies of the present combinations preferably are similar in structure and functioning to the injector holding apparatus described herein and comprise a housing and at least one element, preferably a plurality of elements. The housing is sized and adapted to receive an intraocular lens injector having a loading chamber, and preferably a pair of generally opposing wings, so that the loading chamber is maintained in an open position. The element or plurality of elements are secured to the housing and are adapted and positioned to stabilize the position of the injector relative to the housing, preferably to hold the intraocular lens injector in or to the housing, with the loading chamber in the open position.
The intraocular lens holding assemblies of the present combinations are adapted for removably retaining an IOL, and preferably comprise a holding member having a first side and a substantially opposing second side, and more preferably a hinge, such as a centrally located, longitudinally extending hinge. In one embodiment, the holding member includes a plurality of retaining members extending from the first side and adapted to receive and removably retain the intraocular lens injector. The intraocular lens holding assembly may be considered at least a portion of a packaging system for the IOL.
In one very useful embodiment, the second side of the holding member includes at least one indent, more preferably a hole through the holding member, and the housing includes at least one projection adapted to be introduced into the at least one indent to facilitate the direct transfer of the intraocular lens from the holding member to the intraocular lens injector. More preferably, two spaced apart indents are provided in the holding member and two corresponding or complementary spaced apart projections are included in the housing.
At least one of the housing and the holding member, more preferably both the housing and the holding member, are structured to facilitate the proper positioning of the intraocular lens injector holding assembly and the intraocular lens holding assembly to facilitate the transfer of the injector to the holding member and/or the IOL from the holding member to the intraocular lens injector. For example, the sidewall of the housing may include an off-center, inwardly extending indexing projection (or recess) and the holding member may include a complimentarily sized, off-center indexing recess (or projection). The indexing projection and recess are oriented so that the projection and recess are in mating relation when the housing and holding member are properly positioned to facilitate the direct transfer of the injector to the holding member. This feature very effectively reduces, or even substantially eliminates, the risk of the IOL ultimately becoming improperly placed in the injector.
In a very useful embodiment, the holding member defines a slot, for example, a slot defined by a groove, sized and adapted for removably retaining the intraocular lens.
In an additional aspect of the invention, package systems for intraocular lenses are provided and comprise an elongated holding member and a cover member. The holding member includes a first portion and a second portion with the first portion being adapted for removably retaining an intraocular lens. The cover member includes a top and a bottom and is adapted to receive the first portion of the holding member. The cover member is further adapted to be movable between a closed position surrounding the first portion and an open position to allow the holding member to be removed from the cover member. The second portion of the holding member preferably extends outside the cover member while the first portion is received by the cover member and the cover member is in the closed position. The top and the bottom of the cover member preferably are formed as a unitary structure which further includes a hinge located between the top and the bottom, for example, to facilitate the movement of the cover member between the closed and open positions.
In a particularly useful embodiment, the top of the cover member includes a first fastener member and the bottom of the cover member includes a second fastener member positioned and adapted to cooperate with the first fastener member to hold the cover member in the closed position. The first and second fastener members preferably can be operated by one hand of an adult human to open and close the cover member, as desired. The holding member and the cover member advantageously are configured to removably hold the holding member to the cover member when the holding member is received by the cover member.
The present IOL package systems very effectively protect the intraocular lens during transportation and storage. Since the elongated holding members of the present IOL package systems may, and preferably are, substantially similar to the holding members described elsewhere herein, such elongated holding members can be effectively used in transferring the IOL to an IOL injector, as described herein.
In a still further broad aspect of the present invention, methods for loading IOLs into an injector in preparation for inserting the IOL into an eye are provided. The injector has a load or loading chamber. The present methods comprise:
providing a deformable IOL in an intraocular lens holding assembly adapted for removably retaining the IOL;
providing the injector held in an intraocular lens injector holding assembly including a housing side and adapted to receive the injector so that the loading chamber is maintained in an open position;
positioning the holding member in close proximity to the housing; and
moving the holding member relative to the housing to effect the direct transfer of the injector from the intraocular lens injector holding assembly to the intraocular lens holding assembly.
The present methods preferably further provide for removing the injector and the intraocular lens together from the intraocular lens holding assembly. The injector and IOL can then be placed in an IOL injector system handpiece, of conventional construction. The IOL in the injector, with the injector in the handpiece, is available for insertion into an eye.
The present intraocular lens injector holding assemblies and/or intraocular lens holding assemblies can very effectively be used in the present methods.
Any and all features described herein and combinations of such features are included within the scope of the present invention provided that the features of any such combination are not mutually inconsistent.